Senior Director, Regulatory Advertising & Promotion

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with generous match

Tuition reimbursement

Paid holidays and paid leave programs

Life insurance

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking a regulatory affairs leader to direct and review advertising and promotional materials for prescription drugs and devices in the United States.

The role supports rare disease launches, provides guidance on promotional messaging, and partners with Commercial, Medical, Legal, and Regulatory teams to ensure compliant communications. The candidate will monitor regulatory changes, participate in launch planning, and train staff on promotional compliance.

Qualifications

• 6+ years of experience in pharmaceutical advertising and promotion compliance.
• Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities.
• Experience supporting rare disease products.
• Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments.
• Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment.
• Solid understanding of U.S. regulatory requirements.
• Excellent understanding of medical concepts and terminology.
• Strong understanding of FDA advertising and promotion requirements and applicable product labeling.

Responsibilities

• Directs or reviews promotional labeling materials and communications for prescription drugs and medical devices.
• Provide strategic regulatory guidance during pre-launch and launch activities.
• Review materials to ensure consistency with labeling and regulatory requirements.
• Partner cross-functionally with Commercial, Medical, Legal, and Regulatory teams for launch activities.
• Provide training to internal employees and affiliates on promotional compliance regulations.

Skills

Promotion compliance

Cross-functional collaboration

Regulatory strategy

FDA advertising requirements

Launch planning support

Education

Bachelor's Degree

Advanced degree preferred

Tools

MS Office

Veeva PromoMats

CREDO

Outlook

Teams

Adobe Acrobat

Job description

Otsuka Pharmaceutical Co., Ltd. is seeking a regulatory affairs leader to direct and review advertising and promotional materials for prescription drugs and devices in the United States.

The role supports rare disease launches, provides guidance on promotional messaging, and partners with Commercial, Medical, Legal, and Regulatory teams to ensure compliant communications. The candidate will monitor regulatory changes, participate in launch planning, and train staff on promotional compliance.